MiDiagnostics

At the end of May 2015, imec and Johns Hopkins University announced the launch of a startup company, miDiagnostics. The new company will develop small medical chips, which will be assembled into diagnostic devices that will assist doctors and patients in getting quick diagnoses. CEO, Hilja Ibert, tells us about this revolutionary product. With the motto ‘Think Big, Act Fast’, she immediately sets high expectations for miDiagnostics.

As of February 1, Hilja Ibert has moved into her office located within an imec building in Leuven. From there, she will guide her team of researchers: 30 at imec and 20 at The Johns Hopkins University located in Baltimore, MD USA. The partners’ first priority is developing a prototype of the diagnostic device that can be tested in clinical studies by the spring of 2017. Hilja Ibert: “We plan to present our prototype to interested parties by the end of 2017 after 24 months of development and clinical research. Our diagnostic device will be a POC/PON platform that can be used for numerous applications, including the detection of cells, proteins, small molecules and genetic material (DNA/RNA). Together, with commercial partners, we will adapt the platform to specific applications that represent current unmet clinical diagnostic needs. We will initially focus on the healthcare market, followed by the consumer general wellness as well as veterinary markets.”

The third generation

Experts believe that the miDiagnostics platform will compete with a new generation of diagnostic devices. Ibert: “Today, if you want your blood analyzed, it is done in specialized labs which use first-generation large, complex and expensive equipment. However, now, second-generation smaller less complex and inexpensive instruments are reaching the market, which are more user-friendly and can be used by non-trained healthcare personnel. Finally, the third generation – like our platform – consists of even smaller easy-to-use devices that can be operated by the patient and/or the treating healthcare professional. In addition, these devices can wirelessly transmit encrypted results to a laptop, tablet or smartphone. These innovative diagnostic tools compare to today’s pregnancy or glucose tests, but offer the ability to do many more complex assays.”

A companion for your medication

Which assays and applications will miDiagnostics focus on? Ibert: “Of course, this will depend on our partner companies. However, we intend to develop a platform that can be modified for numerous applications, utilizing four comprehensive pathways.
In order to prove the concept, we will develop some applications on our own. The first developed test will be able to detect and count cells in a blood sample. The complete blood count (a CBC test) will also further differentiate white blood cells, representing the n°1 requested diagnostic test in the world. Doctors use it as a quick test to help inform the health status of a patient. You could imagine that in the future, chemo patients would do the test at home to make sure their white blood cell number is high enough and they are ready for their next treatment. Today, this test for chemo patients is done in the hospital, just before their next chemo session. Thus, they don’t know in advance, if they will get the treatment or not.

A second target for our first devices is metabolites such as ALT or creatinine. These biomarkers are indicators for stressed liver and kidneys, respectively. Our device could be used as so-called companion diagnostics: patients that take medicines which are potentially toxic for their liver or kidney will also find these diagnostic tests in their medication package. The patient will be asked to do the test regularly to confirm they can continue taking the drugs, without damaging their liver or kidneys.

Next, our devices will be able to detect proteins. Think of antibodies that our body produces when attacked by a virus or bacterium. Finally, also nucleic acids (RNA and DNA) will be detectable. Together with a protein test, these tests may reveal a number of blood infections. So when you visit a doctor in the future, they will know for sure whether or not to prescribe you antibiotics. Or you could buy a flu test at the pharmacy and quickly test if your headache and dripping nose are caused by the virus. Suppose that thousands and millions of people would use this same flu test, than it would become possible to collect all these data – anonymously – in the cloud and get an overview of how the flu epidemic is evolving. In addition to the diagnostic device, data could be an amazing instrument for world health!”

All these potential applications clearly illustrate how pharmaceutical and diagnostic companies will want to partner with miDiagnostics. Pharma companies will e.g. use the device as companion diagnostics for their medicines and to easily monitor patients during clinical trials.

The right moment

If you consider some major trends in society today, miDiagnostics and its products are coming at the right moment. Ibert: “The need for diagnostic tests will increase dramatically in the coming years because of the aging population. Also, people are becoming more conscious of their health. I just discovered a health app on my new phone and it’s amazing how I try to beat myself in doing more steps every day. This simple app really motivates me to be more active. Soon, diagnostic tests will also motivate you to live a healthier life. People will go to the pharmacist to do a quick check on their cholesterol or vitamin D.

Next to the health-conscious population in the developed countries, another important market for this new generation of tests will be the developing countries. A true revolution will take place once people get access to easy-to-use and cheap diagnostics. Another trend is the rising pressure on healthcare costs. Our kind of tests can be used to treat patients more effectively outside of the hospital and to prevent them from being hospitalized. Or the patients can be released more quickly because the follow-up can be done in an efficient and trusted way from the home by sending the data to the doctor remotely.”

Not only for society miDiagnostics is coming at the right moment; also for Hilja Ibert it was ‘the right moment’: “I was contacted by a headhunter at the perfect time. Because of my family situation – my children are older now – and because I was looking for an opportunity to be more hands-on and to drive real innovation. Most of the time during my career in the diagnostics business, I had the pleasure to be part in breakthrough innovation. By moving on in these companies towards vice-president and general manager roles, the innovation character of my job became lower. So I wanted to be closer to innovation again. It’s great when you have an impact on how healthcare is done to the good for the patient and for the company you are working for. It’s a good motivator to get up every morning!”